Acute Kidney InjuryNCT07197957
Cystatin and Early AKI Detection Contrast Induced Acute Kidney Injury
An observational study of Acute Kidney Injury, run by BayCare Health System at 4 sites in United States.
Trial summary
To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Mar 2025to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be a cohort of inpatients with CKD. Eligible study participants, as defined by the inclusion criteria, will be consented at Morton Plant North Bay Hospital, Mease Countryside Hospital, and Morton Plant Hospital and St. Anthony's Hospital.
Who may be able to join
- Subjects ages 18 years and above
- Inpatients with CKD (Figure 1)
- Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.
- Pre and post contrast available
- All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.
Who cannot join
- Preexisting dialysis
- Patients under the age of 18 years
- Pregnancy
- Incarcerated individuals
- Patients with impaired cognition and unable to follow consent procedures
- Recent exposure to CM (within 2 days before/after procedure)
- Cardiac shock
- Medications that affect biomarkers, including corticosteroids, lfamethoxazoletrimethoprim
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Morton Plant Hospital
Clearwater, Florida, 33756
Andrea Daigneault, RN, 727-754-9028, andrea.daigneault@baycare.org
- Recruiting
Morton Plant North Bay Hospital
New Port Richey, Florida, 34652
Enrique Rincon, MD, 727-375-7929, enrique.rincon@baycare.org
- Recruiting
Mease Countryside Hospital
Safety Harbor, Florida, 34695
Jonathan Frunzi, MD, (727) 725-6111, johnathan.frunzi@baycare.org
- Recruiting
St. Anthony's Hospital
St. Petersburg, Florida, 33705
Sarah Al-Obaydi, MD, 727-825-1236, sarah.alobaydi@baycare.org
About this study
Official title: Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury
To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).
Read the detailed description
The primary objective of this study is to evaluate the clinical utility of Cystatin C in early detection of contrast-induced AKI.
To evaluate the effect of patient characteristics in the Cystatin C based GFR estimation in comparison to Cr based estimation.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up
Measured: 10 days
Secondary outcomes (1)
Change from baseline in eGFRcr compared to change from baseline in eGFRcys 24-48 hours after contrast media and at 7 to 10 days follow-up
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start11 Mar 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BayCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197957
- Sponsor's protocol ID
- Cystatin & Early AKI Detection
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Cystatin C in the Early Detection of Contrast Induced Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07197957
- Acronym / sponsor ID
- Cystatin & Early AKI Detection
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BayCare Health SystemUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the clinical utility of serum cystatin C in early detection of acute kidney injury (AKI).
Detailed description
The primary objective of this study is to evaluate the clinical utility of Cystatin C in early detection of contrast-induced AKI.
To evaluate the effect of patient characteristics in the Cystatin C based GFR estimation in comparison to Cr based estimation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be a cohort of inpatients with CKD. Eligible study participants, as defined by the inclusion criteria, will be consented at Morton Plant North Bay Hospital, Mease Countryside Hospital, and Morton Plant Hospital and St. Anthony's Hospital.
Key inclusion criteria (5 listed)
- Subjects ages 18 years and above
- Inpatients with CKD (Figure 1)
- Order for CT imaging study or coronary angiography with isohexol Omnipaque) contrast media.
- Pre and post contrast available
- All races and ethnicity of patients are eligible. We expect to analyze approximately equal number of men and women in this study.
Key exclusion criteria (8 listed)
- Preexisting dialysis
- Patients under the age of 18 years
- Pregnancy
- Incarcerated individuals
- Patients with impaired cognition and unable to follow consent procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up
Time frame: 10 days
1 secondary outcome
Change from baseline in eGFRcr compared to change from baseline in eGFRcys 24-48 hours after contrast media and at 7 to 10 days follow-up
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by BayCare Health System at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Johns, PharmD (727-519-1310, tracy.johns@baycare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AKI when sCr is used compared to when sCyC is used 24-48 hours after contract media and at 7-10 days follow-up (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.